MAUDE Adverse Event Report: ANGIODYNAMICS THERMOPAD; RF PAD

Catalog Number	H7877001026230
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported damaged packages have been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: angiodynamics' distributor reported when doing an in-house warehouse inspection of incoming devices, when opening the shipping box, the internal packages were damaged, some exhibited punctures and scrape marks, and one contained a torn seal.The damage to the packages compromised the sterility of the medical devices.As the damage was noted at the distributor's inspection process, there was no patient involvement.The damaged packages have been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was a shipper box that contained 23 pouches of dispersive pads.A visual/microscopic examination of the returned product noted damage to the shipping box and the inner packaging.The customer's reported complaint description of the packaging was ripped and dirty is confirmed.The root cause is handling damage of the product after the product left the angiodynamics facility, as qa personnel to 100% visually inspect to verify there are no shipping damage.This type of damage would be noticed prior to shipment.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: THERMOPAD
• Common Device Name: RF PAD
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7719466
• Report Number: 1317056-2018-00146
• Device Sequence Number: 903906
• Product Code: GEI
• UDI-Device Identifier: H7877001026230
• UDI-Public: H7877001026230
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K031926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: H7877001026230
• Device Lot Number: Y120417-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1